GEMFIBROZIL
- Product NDC
- 31722-128
- 11-digit product format
- 317220128
- Labeler code
- 31722
- Product ID
- 31722-128_0b03cc05-5962-498a-aa5d-5f18c844cc09
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Gemfibrozil
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA214603
- Marketing category
- ANDA
- Marketing start
- 2021-01-20
- Substance
- GEMFIBROZIL
- Active strength
- 600 mg/1
- Pharmacologic classes
- PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- GEMFIBROZIL
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GEMFIBROZIL | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Q8X02027X3 |
| Rxcui | 310459 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 31722-128-05 | GEMFIBROZIL | 500 in 1 BOTTLE | TABLET | 500 | | 3 |
| 31722-128-60 | GEMFIBROZIL | 60 in 1 BOTTLE | TABLET | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-128 | GEMFIBROZIL TABLET [CAMBER PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20211008_f6a2362a-21e1-442d-9f5d-9e600b5a2ea8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 31722-128-05 | 31722012805 | 500 TABLET in 1 BOTTLE (31722-128-05) | 500 tablet | 2021-01-20 | 0000-00-00 | No | No | Current |
| 31722-128-60 | 31722012860 | 60 TABLET in 1 BOTTLE (31722-128-60) | 60 tablet | 2021-01-20 | 0000-00-00 | No | No | Current |